Learn more about our policy experts.

Media Contacts

Angela Bradbery, Director of Communications
w. (202) 588-7741
c. (202) 503-6768
abradbery@citizen.org, Twitter

Don Owens, Deputy Director of Communications
w. (202) 588-7767

David Rosen, Press Officer, Regulatory Affairs
w. (202) 588-7742

Luis Castilla, Press Officer, Public Citizen’s Texas office
w. (512) 637-9467

Other Important Links

Press Release Database
Citizen Vox blog
Texas Vox blog
Consumer Law and Policy blog
Energy Vox blog
Eyes on Trade blog

Follow us on Twitter


Bioethics and Medical Experts Join Chorus of Criticism of Inadequate Consent Procedures in NIH Baby Study

June 27, 2013

Forty-five experts have declared that a federally funded trial involving premature infants used “seriously deficient” consent forms that violated requirements for clinical trials.

In a letter published Wednesday in The New England Journal of Medicine (NEJM), available at http://www.nejm.org/doi/full/10.1056/NEJMc1308015, the 45 doctors, bioethicists and scholars criticized the consent forms used in the SUPPORT trial, which took place in approximately two dozen prominent research facilities throughout the country from 2005-2009. In the trial, 1,316 premature infants were exposed to an increased risk of blindness and death. One primary purpose of the research, funded by the National Institutes of Health (NIH), was to determine whether extremely premature infants were more likely to die if treated with high or low amounts of oxygen.

The Office for Human Research Protections also has found the consent forms to be inadequate.

The experts noted that the risks to the babies in the study were not the same as the risks they would have encountered had they received the usual routine care outside the study. The risk of a baby dying was indeed foreseeable, which the consent form didn’t mention, they noted. The law requires consent forms to include, among other things, a description of any reasonably foreseeable risks.

Since Public Citizen publicized the trial in April (http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3859) and called for similar trials to be halted, a controversy has raged in the scientific community over what kind of consent is needed in clinical trials. The debate goes to the heart of how research is conducted in the United States and could have far-reaching implications if changes are made to the standards by which trials are run.

“None [of the forms] specifically mentioned death as a possible risk of the oxygen interventions in the study,” the experts wrote in the NEJM letter. “The oxygen interventions in the study differed from usual clinical care, and that information should have been included in the consent forms.”

In addition, Public Citizen has subsequently learned that problems with the study extend beyond the consent forms; the oxygen monitors were deliberately miscalibrated so that the doctors treating the infants didn’t know how much oxygen they were receiving. This miscalibration, done for the purpose of the oxygen experiment, could have adversely affected numerous critically important clinical decisions regarding the care of these babies beyond those related to oxygen treatment. However, parents of study babies weren’t informed about these risks either.

For more information about the trial, please visit http://www.citizen.org/hrg2111.


© 2013 Public Citizen • 1600 20th Street, NW / Washington, D.C. 20009 • unsubscribe

Copyright © 2017 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


You can support the fight for greater government and corporate accountability through a donation to either Public Citizen, Inc., or Public Citizen Foundation, Inc.

Public Citizen lobbies Congress and federal agencies to advance Public Citizen’s mission of advancing government and corporate accountability. When you make a contribution to Public Citizen, you become a member of Public Citizen, showing your support and entitling you to benefits such as Public Citizen News. Contributions to Public Citizen are not tax-deductible.

Public Citizen Foundation focuses on research, public education, and litigation in support of our mission. By law, the Foundation can engage in only very limited lobbying. Contributions to Public Citizen Foundation are tax-deductible.